The following data is part of a premarket notification filed by Madison Polymeric Engineering with the FDA for Cygnus Electrosurgical Tip Cleaner.
| Device ID | K965086 |
| 510k Number | K965086 |
| Device Name: | CYGNUS ELECTROSURGICAL TIP CLEANER |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | MADISON POLYMERIC ENGINEERING 495 WARD ST. EXTENSION Wallingford, CT 06492 |
| Contact | Shaun Sweeney |
| Correspondent | Shaun Sweeney MADISON POLYMERIC ENGINEERING 495 WARD ST. EXTENSION Wallingford, CT 06492 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-19 |
| Decision Date | 1997-02-14 |
| Summary: | summary |